CN102271578B - 使用便携式电子内脏造影系统的胃肠功能的评估及其使用方法 - Google Patents

使用便携式电子内脏造影系统的胃肠功能的评估及其使用方法 Download PDF

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CN102271578B
CN102271578B CN2009801543873A CN200980154387A CN102271578B CN 102271578 B CN102271578 B CN 102271578B CN 2009801543873 A CN2009801543873 A CN 2009801543873A CN 200980154387 A CN200980154387 A CN 200980154387A CN 102271578 B CN102271578 B CN 102271578B
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乔治·萨瓦奇
霍曼·哈菲奇
奥利弗·科利乌
马克·兹德布利克
安吉拉·斯特兰德
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Abstract

本发明提供了便携式电子内脏造影系统。该系统的方面包括与身体相连的接收器和可摄入的识别器单元，这两者被配置成检测内脏电信号。系统与体外数据处理器通信，体外数据处理器被配置成从与身体相连的接收器接收数据并从所接收的数据生成内脏电图。本发明还提供使用本发明的系统产生内脏电图的方法。

Description

使用便携式电子内脏造影系统的胃肠功能的评估及其使用方法
交叉引用
根据美国法典第35卷第119条(e)款，本申请要求于2008年12月11日提交的序列号为61/121,878的美国临时申请、于2008年12月11日提交的序列号为61/121,881的美国临时申请的提交日期的优先权，上述申请的每个的公开通过引用被全部并入本文。
技术领域
本发明涉及电子系统，并且更具体地涉及用于确定由受检者生成的电信号的电子系统。
背景
胃肠紊乱是造成各种不同的医学病症的原因。一种类型的胃肠紊乱是胃能动性紊乱。胃能动性紊乱可以包括胃节律紊乱(如胃动过缓和胃动过速)、胃轻瘫以及胃出口梗阻。胃能动性紊乱可由多种不同的原因例如糖尿病继发自主神经病变、以前的腹部手术、各种疾病如自身免疫性紊乱、药物副作用等引起。胃能动性紊乱的症状可变化，并可包括恶心、呕吐、胃气胀和腹部不适。这些症状可能是轻微的，或者可能发展成慢性的、严重的或者甚至衰弱病症，其不利地影响个体的身体和/或精神健康。
另一种类型的胃肠紊乱是胃食管逆流病(GERD)，它的特征为由食道中的异常逆流产生的慢性症状或粘膜损害。DeVault KR，Castell DO(1999)“Updated guidelines forthe diagnosis and treatment of gastroesophageal reflux disease.The PracticeParameters Committee of the American College of Gastroenterology”Am.J.Gastroenterol.94(6)：1434-42。GERD可能由食道和胃之间的屏障中的瞬时或永久性变化引起。这些变化可能由下食道括约肌的机能不全、瞬时下食道括约肌松弛、来自食道的胃逆流的受损排出或食管裂孔疝引起。
存在与胃肠紊乱相关的各种不同的检验。为评估胃能动性发展的一种类型的检验是胃排空闪烁摄影(GES)检验。GES被认为是对胃轻瘫的金标准诊断检验。可对胃能动性紊乱采用的其它检验包括钡研究、超声波、CAT扫描、核磁共振成像(MRI)、内窥镜检查、测压法和胃电图。
胃电图(EGG)是由胃电图描记器产生的图形，胃电图描记器记录穿过胃部肌肉传播并控制胃部肌肉的收缩的肌电信号。胃肠电图(或胃肠图)类似于胃电图，除了使用由胃和肠产生的电信号之外。
为获得胃电图和胃肠电图，传感器(如电极)被施加于患者的皮肤表面并被用来检测指示胃肠系统或其中所关注的区域的肌肉活动的电信号。
目前正在使用的采用皮肤表面读数的系统的问题是，与腹部肌肉活动有关的电信号很难与指示胃肠系统的肌肉活动的电信号区分开。因此，需要用于准确地读取并检测指示胃肠系统的肌肉活动的电信号的系统和方法。
概述
根据本发明的教导，公开了用于捕获与胃肠系统的肌肉活动相关的电信号的系统和方法。本文所公开的系统和方法可与评估受检者的胃肠功能的电子内脏造影系统和方法一起使用。该系统的方面包括可摄入识别器标识器和与身体相关连的接收器，所述接收器被配置成检测电信号。该系统被配置成从识别器单元或标识器接收数据。该信息可以被用来从所接收的数据生成内脏电图。根据本发明还提供使用标识器和接收器来产生内脏电图的方法。
附图说明
图1是连接到受检者的接收器单元和由受检者摄入的识别器单元的示例性实例。
图2A是根据本发明的教导的图1的识别器单元的横截面侧视图。
图2B是图2A的识别器单元的俯视图。
图3是图2A的识别器单元的集成电路的功能部件方块图。
图4是图3的集成电路的检测单元的功能部件方块图。
图5是图1的接收器单元的功能部件方块图。
图6是图1的接收器单元的方块图表示。
图7示出用于创建使用接收器协调位置的识别器单元的阵列的系统。
详细说明
参考图1，示出具有电子内脏造影系统的一部分的受检者，所述系统根据本发明的教导收集有关受检者的数据。电子内脏造影系统包括与身体相关连的接收器单元20和识别器单元22。体外数据处理器24与接收器单元20通信。体外数据处理器24可采用各种配置，例如具有内置或外围监视器的计算机(例如可在床边监视器或健康信息系统中找到)、个人数字助理(PDA)、智能电话、消息发送设备等。为了向体外数据处理器24提供数据，接收器单元20可被配置成将所接收的信号的数据重新发送到在所述受检者外部的位置。可选地，接收器可以被配置成由外部询问设备询问以向外部位置提供所接收的信号的数据。可采用任何方便的数据传输协议，包括有线和无线数据传输协议。
本发明的电子内脏造影系统是被配置成产生内脏电图的系统。内脏电图是指任何可用的数据表现形式，例如可用于评估受检者的胃肠功能的图形化报告。胃肠信息包括提供有关内脏器官或胃肠系统或其一部分的肌电活动的信息的一个或多个参数。受检者的内脏器官是身体的软内部器官，特别是被包含在腹腔和胸腔中的那些器官。所关注的是涉及能动性的器官，如胃肠道的器官。术语“胃肠”与胃和肠有关。短语“胃肠系统”总体上指胃、小肠和大肠以及相关的结构，例如食道等。因此，由本发明的系统产生的内脏电图包括肠电图和胃电图。所关注的其他的内脏器官包括尿道的器官如膀胱等。
根据本发明的一个方面，受检者摄入识别器单元22以便启动识别器单元22。如图1的当前实例所示的，识别器单元22处于摄入的最后阶段。接收器单元20被示为在期望位置处固定到受检者。接收器单元20的位置可由医疗需求和系统设计确定。根据本发明的方面采用的接收器单元20是被配置成与身体位置(或者身体的内部或者表面上)相关连并从身体的一个或多个内脏器官如胃肠道或其一部分如胃、小肠、大肠等检测电信号的那些接收器单元。如下详细描述的，使接收器单元20连接到受检者的衣服上而只将电极导线/电线固定到受检者的皮肤也在本发明的范围内。
现参考图2A和2B，识别器单元22包括集成电路部件30、上电极32、下电极34和信号放大元件36。根据本发明的教导，上电极32和下电极34可分别具有任何方便的形状，例如方形、圆盘等。信号放大元件36是平面圆盘结构，其中信号放大元件36的边缘延伸超出上电极32和下电极34的边缘。在所描绘的实施方式中，信号放大元件36的半径比上电极32和下电极34的半径长例如1毫米或更多，例如10毫米或更多。
信号放大元件36的边缘可延伸超出电极32和34的边缘的距离可变化，并且在某些实施方式中为0.05毫米或更大，例如，0.1毫米或更大，包括1.0毫米或更大，例如5.0毫米或更大并且包括10毫米或更大，其中在某些实施方式中，该距离不可超过100毫米。上电极32和下电极34被配置成使得当与导电流体如胃液接触时产生电压电位并且电流流过集成电路30以使集成电路30中的一个或多个功能块在识别器单元22在广播模式下工作时产生独特的电流特征。上电极32和下电极34之间产生的电压电位通过构成电极32/34的材料和周围导电流体之间的化学反应产生。在广播模式下，电流路径50在上电极32和下电极34之间通过围绕识别器单元22的导电流体形成。
现参考图3，集成电路30包括电耦合到检测单元40和感测单元41的控制单元38。在广播模式下，集成电路30的控制单元38分别控制上电极32和下电极34之间的电导。通过控制电导，识别器单元22能够产生独特的电流特征，并对其中由识别器单元22在检测模式过程中搜集的数据编码。在检测模式下，检测单元40检测内脏器官或胃肠系统或其一部分的肌电活动。肌电信号的频率范围从几赫兹到约300赫兹，并且电压范围从约10微伏到1毫伏。根据实施方式，识别器单元22的启动的目标生理部位或位置可变化。所关注的代表性目标生理部位包括但不限于：胃肠道中的位置，如口腔、食道、胃、小肠、大肠等。识别器可以被配置成当与目标部位处的流体例如胃液接触时被启动，而与目标部位的特定组合物无关。在期望时，识别器可以被配置成在组合物与目标生理部位接触之后通过询问来启动。识别器单元22可被配置成在目标部位启动，其中在指定时间段后到达目标部位。
感测单元41包括用于感测和检测与环境相关的不同参数的电路。例如，感测单元41可以是温度感测或pH感测单元或其组合。可包括其它生理参数感测传感器。
现参考图4，检测单元40包括用于给电路供电的电力线/信号线40a和40b，当识别器单元22在检测模式下工作时，所述电路检测内脏器官的肌电活动。肌电电流通常是较低频的电流源。电力线40a和40b电耦合到齐纳二极管42和电容器44用于电源控制。另外，电力线40a和40b与电容器46和48及放大器50并联地电耦合，用于检测和过滤与内脏器官的肌电活动相关的电信号。更具体地，信号通过放大器50。经放大的信号被传递到带通滤波器单元52。滤波器单元52除去信号的高频部分，使得肌电活动和相关信号被留下。经过滤的信息被传递到峰值检测单元54。峰值检测单元54用于确定信号是否与真正的肌电活动相关以及该活动是否接近识别器单元22，所有这些可由出现的峰值功率或尖峰信号确定。峰值检测单元54能够使用期望的检测参数来调整参考或基线值。如果电压电位中存在超过由峰值检测单元54设置的阈值的峰值，那么峰值尖峰信号被传递给模式识别单元56以确定肌电信号的性质和类型。模式识别单元56的输出由信号确认模块58、IPG滤波器60、生理参数滤波器62以及第二生理参数滤波器64接收。每个滤波器60、62和64被设置成确定并只允许特定类型的检测到的电活动通过每个滤波器的界定范围。例如，如果由识别器单元22所检测和收集的信息是低频肌电电流，则信息将只通过三个滤波器60、62和64中的一个到达连接器39。任何数量的滤波器可以根据正被评估的参数被添加到检测单元40。例如，一个滤波器可被添加以只允许pH有关的信息传递给控制单元38。一旦该信息通过检测单元40上的滤波器之一被传递，则数据或信息被发送到控制单元38，其中它被编码为控制单元38产生的独特电流特征的部分。这种独特的电流特征由系统的接收器单元检测并解码。
根据本发明的一些方面，识别器单元22在生理上被依尺寸制造，这意味着它单独地或与其它赋形剂相结合而与摄入兼容。在某些方面，识别器单元可与载体如活性药剂或其它赋形剂相关。例如，生理大小的识别器单元可具有10立方毫米或更小的尺寸，例如5立方毫米或更小，包括1立方毫米或更小。在其它情况下，识别器单元22可被依尺寸制造以在摄入之后留在胃里，至少直到识别器单元22通过胃的消化活动被破坏为止。在这些情况下，识别器单元22可被配置成具有1平方厘米或更大例如10平方厘米或更大的表面积。
接收器单元20和识别器单元22被配置成检测电场或磁场信号。处理器24可被用于或配置成通过任何通信手段包括无线和有线方法从接收器单元20接收数据。处理器24可以从所接收的数据生成内脏电图。所关注的接收器单元20包括被依尺寸制造成以实质上不影响活体受检者运动的方式稳定地与活体受检者相关联的那些接收器单元。因此，接收器单元20可具有当对受检者如人类受检者使用时不会使受检者经历其移动能力的任何差异的尺寸。在一些情况下，确定接收器单元20的尺寸使得其大小不妨碍受检者身体移动的能力。在期望时，接收器单元20具有小尺寸并可占据5立方厘米或更小例如3立方厘米或更小包括1立方厘米或更小的空间体积。在一些情况下，接收器具有从10平方毫米至2平方厘米范围的芯片尺寸限制。
现参考图5，接收器单元20包括定位在外壳72中的处理单元70。处理单元70电耦合并连接到电极74。线圈76缠绕在外壳72周围并电耦合到处理单元70。线圈76缠绕在周边周围并提供从接收器单元20装置到图1的体外数据处理器24的信号传输。在当前的实例中，接收器单元20包括两个电极。然而，根据本发明的另一方面，接收器单元20可包括其他的电极并且本发明的范围不受电极数量的限制。因此，在所关注的一个配置中，接收器单元20包括一个或多个电极(例如两个或更多电极、三个或更多电极和/或包括多个例如两个或更多、三个或更多、四个或更多对电极等)，用于检测由所关注的内脏器官发射的电信号以及检测来自识别器单元22的电流特征。在所关注的一个配置中，接收器单元20包括彼此分隔开距离“X”的两个电极，该距离可以是允许电极检测差动电压的距离。此距离可变化，且范围可从0.1厘米至5厘米，例如从0.5厘米至2.5厘米。电极也可以用作天线以接收与识别器单元或标识器相关的特征电流。
接收器单元20可包括各种不同类型的信号接收器元件和处理协议，只要接收器单元20被配置成检测期望的内脏电信号。另外，所关注的接收器单元可以是外部的和可植入的。
现参考图6，处理单元70包括放大器80，其检测图5的电极74两端的差动电压电位。该电压电位差代表电极两端的肌电信号。电位通过导线82发送到放大器80，导线82通过放大器电连接到图5的电极74。所检测的信号然后进入解调器84。还示出存储器单元85以储存经解调的数据、所接收的信号、生理参数数据以及医疗记录数据。时钟86写入存储器单元85以便给事件加时间戳。传输单元89将数据从存储器单元85传送到图1的体外数据处理器单元24。处理单元70还包括电耦合到微处理器88的电源87。微处理器88协调各个功能块之间的功能以及电源管理。
根据本发明的各个方面，本发明的系统可包括单个接收器单元或多个接收器单元。对于包括单个接收器单元的系统，接收器单元可包括三个或更多不同电极，并可被配置成定位在受检者的腹部或剑突(xyphoid)区域中。这样的系统的接收器单元可按需要被放置在任何方便的位置，例如躯干的前面、躯干的后面等。在具有多个接收器单元的系统中，每个接收器可具有单个电极并且这样的接收器可相互通信以产生接收器单元的阵列。
接收器单元的可植入版本的方面将具有生物相容的外罩、一个或多个感测电极、电源，电源可以是原电池或可再充电电池或者通过向线圈感应地广播来供电的电源。对于外部信号接收器，实施方式包括具有与皮肤相对的电极的结构。通信可以是无线的或经由一个或多个传导媒介例如电线、光纤等执行。在期望时，相同的电极可用于接收和传输信号。
在某些实施方式中，本接收器的部件或功能块存在于集成电路上，其中集成电路包括若干不同的功能块，即模块。在给定的接收器内，至少一些例如两个或更多——一直到包括全部——功能块可以存在于接收器中的单个集成电路中。所谓单个集成电路指的是包括所有不同的功能块的单个电路结构。因此，集成电路是单片集成电路，其是在半导体材料的薄衬底的表面中制造的微型电子电路(其可包括半导体器件以及无源部件)。本发明的某些实施方式的集成电路可以是混合集成电路，其是由结合到衬底或电路板的单独的半导体器件以及无源部件构成的微型电子电路。
所关注的信号接收器包括但不限于在以下的申请中公开的那些接收器：公布为WO2006/116718的序列号为PCT/US2006/016370的PCT申请、公布为WO2008/063626的序列号为PCT/2007/24225的PCT申请、公布为WO/2008/095183的序列号为PCT/US2008/52845的PCT申请，这些申请的公开通过引用被并入本文。
根据本发明的其它方面，系统可包括两个或更多(例如三个或更多，包括四个或更多)接收器单元。在这样的系统中，两个或更多与身体相关连的接收器可合适地布置在受检者的身体上的任何期望的位置处。例如，所有与身体相关连的信号接收器可存在于身体的同一侧如身体的前躯干上，或者它们可以存在于身体的两侧如身体躯干的前面和后面上。
除了一个或多个与身体相关连的信号接收器以外，本发明的系统可包括体外数据处理器，其被配置成从与身体相关连的接收器接收数据并从所接收的数据生成内脏电图。体外数据处理器单元24可直接从接收器单元或通过数据中继设备(例如从接收器单元接收数据并然后将所接收的数据转发至体外数据处理器的设备)接收电信号数据。根据需要，体外数据处理器单元24可被配置成通过任何方便的有线或无线协议接收数据。所关注的体外数据处理器是可以接收电信号数据并处理数据以产生内脏电图的那些体外数据处理器。所产生的内脏电图可通过任何方便的媒介输出给用户，例如将内脏电图写在纸上、通过图形用户界面向用户显示内脏电图，等等。本发明的系统的体外数据处理器可采用各种配置，例如具有内置或外围监视器的计算机(例如体现为床边监视器或健康信息系统)、个人数字助理(PDA)、智能电话、信息设备等。
在一些情况下，识别器单元识别器是环境敏感的。所谓环境敏感指的是识别器被配置成当识别器遇到识别器被设计以响应的一个或多个条件时被启动。所关注的识别器可以被配置以响应的环境条件包括温度、压力、pH、分析物存在等。在一些情况下，识别器是pH敏感的，所谓pH敏感指的是识别器被配置成响应于预定的pH条件，例如酸性或碱性条件。例如，识别器可以被配置成在它接触具有酸性pH(例如pH 6.5或更小，例如pH 6或更小)的流体或具有碱性pH(例如pH 7.5或更大，例如pH 8或更大)的流体时作出响应(例如通过信号的触发和发射)。在环境敏感识别器响应于它们所接触的预定条件或两个或更多条件的组时，它们被配置成当遇到预定条件或条件组时触发并发射信号。
根据特定应用的需要，由接收器单元检测的来自识别器单元的电流可以是一般的，以便它只识别出该识别器已接触目标部位。可选地，该信号可以代表有关识别器单元所检测的肌电活动的信息。因此，识别器可以是一种这样的识别器，其在以一批剂量使用时发射不能与由该批的任何其它剂量成员的识别器发射的信号区分开的信号。可选地，该批的每个成员可具有识别器，其发射至少相对于该批的成员的所有其它识别器独特的信号。在这些情况下，该批的每个识别器发射至少相对于该批的所有其它识别器唯一地识别该批中的特定识别器的信号。识别器可发射独特的信号，其普遍地是独特信号(其中这样的信号可类似于人的指纹，其与任何其他个体的任何其他指纹不同，并因此在通用级别上唯一地识别个体)。信号可以直接传送关于给定事件的信息，或者提供识别代码，其可用于从数据库检索有关该事件的信息(例如链接识别代码与组合物的数据库)。
识别器可生成各种不同类型的信号，包括但不限于：通过控制电导产生的电流特征、RF信号、磁信号、导电(近场)信号、声信号等。识别器的传输时间可变化，其中在某些情况下，传输时间范围可从0.1微秒到48小时或更长，例如从0.1微秒到24小时或更长，例如从0.1微秒到4小时或更长，例如从1秒到4小时，包括从1分钟到10分钟。根据给定的实施方式，识别器可产生一次独特的电流特征。可选地，识别器可被配置成产生两次或更多次具有相同信息(相同信号)的独特电流特征，其中离散的相同信号的集合可统称为冗余信号。
在一些情况下，识别器标识器可被配置成一旦它到达胃肠道的位置，就保持在该位置。例如，标识器可包括黏膜粘合元件，其在与胃肠道的内部位置接触时将使标识器保持在该位置。这样的实施方式的使用的实例是，其中包括黏膜粘合元件的多个识别器单元被施用到受检者。这些标识器将粘附于胃的不同位置并将从不同位置发射信号。多个不同的信号可被用来产生胃的图，其可随着时间的过去被监测。在期望时，可响应于不同状态如进餐时间、空腹等监测该图。
识别器可根据特定的实施方式和组合物的预期应用而变化，只要它们在与目标生理位置如胃接触时被启动(即接通)。识别器可包括启动部件例如由胃酸完成的电池、以及传输元件。所关注的不同类型的识别器的实例包括但不限于在以下申请中所描述的那些识别器：公布为WO/2006/116718的序列号为PCT/US2006/016370的PCT申请、公布为WO/2008/052136的序列号为PCT/US2007/082563的PCT申请、公布为WO/2008/063626的序列号为的PCT/US2007/024225的PCT申请、公布为WO/2008/066617的序列号为PCT/US2007/022257的PCT申请、公布为WO/2008/095183的序列号为PCT/US2008/052845的PCT申请、公布为WO/2008/101107的序列号为PCT/US2008/053999的PCT申请、公布为WO/2008/112577的序列号为PCT/US2008/056296的PCT申请、公布为WO/2008/112578的序列号为PCT/US2008/056299的PCT申请和序列号为PCT/US2008/077753的PCT申请以及于2009年9月21日提交的序列号为12/564,017的美国专利申请，上述的公开通过引用被并入本文。
除了上述识别器部件以外，在本发明的方法中采用的识别器可与赋形剂组分相关。赋形剂组分可包括一种或多种组成部分，包括但不限于填充剂、粘合剂、崩解剂、着色剂等。所关注的赋形剂组分在公布为WO2006/116718的序列号为US2006/016370的PCT申请中被进一步评述，该申请的公开通过引用被并入本文。可以在本发明的组合物中出现的组分的其他公开可以在Remington’s Pharmaceutical Sciences，Mace出版公司，费城，Pa.，第17版(1985)中找到。识别器单元可以被配置成各种不同的形式。所关注的形式包括固体形式，如药片、粉末、包衣颗粒、填充胶囊等。
根据特定方法，识别器单元可不包括药用活性剂。因此，识别器和构成识别器单元的任何一种或多种赋形剂组分不包括活性剂。在另外其它的实施方式中，识别器单元包括活性剂。如本文所使用的，术语“活性剂”包括当接触活的有机体例如人时产生生理结果例如有益或有用结果的任何化合物。活性剂可与赋形剂组分如填充剂、粘合剂、着色剂等区分开。活性剂可以是能够调节活体受检者的生物过程的任何分子。在一些情况下，活性剂可以是用在诊断、治疗或预防疾病中或作为药物的组分的物质。所关注的活性剂的广泛类别包括但不限于：心血管制剂；止痛剂，例如镇痛剂、麻醉剂、消炎制剂等；神经作用剂；化疗(如抗肿瘤)制剂等。所关注的活性剂进一步在公布为WO2006/116718的序列号为US2006/016370的PCT申请中被公开，该申请的公开通过引用被并入本文。
给定识别器单元可包括单个识别器或者两个或更多识别器。识别器可相对于标识器的其它部件按照各种不同的配置布置。在标识器包括作为赋形剂的药片的场合，一个或多个识别器可被布置在药片式赋形剂的表面上。在一些情况下，标识器由存在于可摄入容器中的两个或更多识别器组成。例如，多个识别器单元识别器可存在于由当与胃液接触时即溶解的材料制造的胶囊中。所关注的可制造载体部件的材料包括生理上可接受的聚合材料，其按照常规药物胶囊剂量使用。材料可以是透明的或不透明的，并按需要可以着色。所关注的是刚性和有弹性的材料。可制造本发明的载体部件的合适聚合物包括但不限于：聚乙烯醇(PVA)；天然及合成多糖，包括支链淀粉、卡拉胶、黄原胶、壳聚糖琼脂树脂和纤维素材料，如羧甲基纤维素、羟丙基甲基纤维素(HPMC)、甲基纤维素、羟乙基纤维素、羟乙基甲基纤维素、羟丙基纤维素；聚乙二醇(PEG)、聚环氧乙烷(PEO)、PEG和PEO的混合物；丙烯酸和甲基丙烯酸基聚合物，如EUDRAGIT ETM、EUDRAGIT LTM和/或EUDRAGIT STM甲基丙烯酸聚合物)，EUDRAGIT RLTM和/或EUDRAGIT RSTM甲基丙烯酸铵共聚物；聚维酮(聚乙烯基吡咯烷酮)，聚乙二醇化甘油酯(如GELUCIRE 44/14TM，GELUCIRE50/02TM，GELUCIRE 50/13TM和GELUCIRE 53/10TM聚合物)；羧乙烯基聚合物(如CARBOPOLTM聚合物)；聚氧乙烯-聚氧丙烯共聚物(如POLOXAMER188TM聚合物)；等等。胶囊部件可以使用任何方便的方案制作，包括模塑等。所关注的制造方案包括但不限于第5,705,189、4,576,284、4,591,475、4,655,840、4,738,724、4,738,817和4,790,881号美国专利中所描述的那些，上述专利的公开通过引用被并入本文。可选地，胶囊部件可从商业供应商如Qualicaps公司、Whitsett NC得到。
产生受检者的内脏电图的方法也被提供。如上所评论的，内脏电图是任何可用的数据表现，例如图形报告(其可被写到物理媒介上或显示在监视器上，等等)，其提供关于受检者的一个或多个内脏器官的肌电活动的信息。所关注的内脏器官包括涉及能动性的器官，如胃肠道的器官，例如胃和肠。因此，由本发明的系统产生的内脏电图包括肠电图和胃电图。所关注的其他内脏器官包括尿道的器官，如膀胱等。
在实施本发明的方法中，如上所述，使用系统的一个或多个与身体相连的信号接收器检测由所关注的内脏器官如胃或肠产生的电信号(例如肌电信号)。所产生的检测的电信号数据然后被转发到体外数据处理器，其接收数据并从所接收的数据生成期望的内脏电图。给定方法可包括在给定时间段内检测电信号，例如一个小时或更长、两个小时或更长、十二个小时或更长、一天或更长、两天或更长、一个星期或更长、两个星期或更长、一个月更长、六个月或更长，包括一年或更长。在本发明的系统是便携式的时，根据需要，可在这些时间段内连续地检测并记录数据。
根据特定应用，与身体相连的信号接收器可相对于所关注的器官按照各种不同的配置定位。例如，在采用单个与身体相连的信号接收器的场合，这些方法可包括将单个接收器最初定位或移植在所关注的器官附近的位置。在所关注的器官是胃的场合，根据需要，单个接收器可被定位在腹部或剑突区域。使用包括两个或更多信号接收器的其他系统，接收器可定位在各种身体位置。例如，这些方法可包括将两个或更多不同的接收器定位在不同的腹部位置(例如，在识别器单元通过胃肠道时，提供识别器单元的三角定位能力)，或将一个接收器定位在前腹部位置并将第二接收器定位在背部位置。该后一种配置代表接收器被放置在目标器官的相对侧上例如以测量整个器官的阻抗的情况。测量通过胃的阻抗作为评估胃能动性的独立方式得到利益，该方式可与本发明的内脏电图结合使用或与其独立地使用。例如，所测得的通过胃的的阻抗将根据胃是满的还是空的而改变。通过使阻抗与食物摄取后的时间关联，可以很容易地产生胃能动性的测量。
在一些情况下，识别器单元识别器是环境敏感的。所谓环境敏感指的是识别器被配置成当识别器遇到识别器被设计响应的一个或多个条件时被启动。所关注的识别器可以被配置以响应的环境条件包括温度、压力、pH、分析物存在等。在一些情况下，识别器是pH敏感的，所谓pH敏感指的是识别器被配置成响应于预定的pH条件，例如酸性或碱性条件。例如，识别器可以被配置成在它接触具有酸性pH(例如pH 6.5或更小、例如pH 6或更小)的流体或具有碱性pH(例如pH 7.5或更大、例如pH 8或更大)的流体时作出响应(例如通过信号的触发和发射)。在环境敏感识别器响应于它们所暴露的预定的条件或两个或更多条件的组时，它们被配置成当与预定条件或条件组接触时触发并发射信号。
对于本发明的pH敏感识别器单元，可使用若干不同的方法将pH敏感性赋予标识器。例如，标识器可包括pH传感器元件，该元件被配置成检测标识器可被放置在其中的给定环境的pH，并对其响应来启动识别器。具有集成pH传感器的识别器的一个实例是包括集成电路和三个不同的电极元件的识别器，这三个电极元件的两个作为在识别器与导电媒介接触时产生的电池的部件，并且其中的第三电极元件(例如由铂或其他合适的材料制造)作为每个电池电极的反电极，三个电极元件的两个作为部分电源的部分和广播模式的部分，而第三个在检测模式过程期间的操作中被使用。集成电路还包括带隙基准。在操作期间，当识别器接触合适的导电媒介如胃液时，电池电极提供集成电路的工作电压，包括集成电路的时钟部件。识别器发射代表来自电路上的带隙基准的温度和电池电极电压的一个或多个信号。同样从识别器传输的是一个或多个信号，其提供基准电极相对于每个电池电极上的电压(例如电池电极1相对于Pt基准电极和电池电极2相对于Pt基准电极)，其中这些电压涉及环境的pH和温度。这些信号可以作为数字信号或频率或占空比被传输。使用这样的识别器，然后例如通过与身体相连的接收器和/或体外数据处理器来处理一个或多个被传输的信号，以例如通过使用查表或适当的算法将代表温度和电池/基准电极电压的信号转换成pH值。可以用来将pH敏感性赋予给定标识器的另一方法是包括涂覆识别器的启动部件(如电池元件)的pH敏感涂层，其中pH敏感涂层只在期望的pH值条件出现时才溶解以使启动部件暴露。所关注的pH敏感涂层包括但不限于：邻苯二甲酸醋酸纤维素、EUDRAGIT LTM、EUDRAGIT STM、EUDRAGIT FSTM以及其他纤维素衍生物的邻苯二甲酸盐。可以用来获得环境敏感性的其他的标识器配置包括但不限于在公布为WO2008/052136的序列号为PCT/US2007/082563的PCT申请中所描述的配置，该申请的公开通过引用被并入本文。
在一些情况下，pH敏感性由识别器单元提供，识别器单元根据其所暴露的环境的特定pH来发射不同的信号。例如，识别器可包括三个电极，其中之一涂有pH敏感涂层，pH敏感涂层只在特定的pH下溶解以暴露电极。在这种类型的识别器中，第一信号将通过未涂覆的电极传输，而当被涂覆的电极上的涂层例如通过溶解被移除时，可与第一信号区分开的第二信号将通过电极传输。在又一实例中，识别器可包括化学药剂，例如通过在用pH敏感涂层密封的室中包括所述药剂而使其在暴露于特定pH时被释放。当移除pH敏感涂层时，所述药剂被释放并修改识别器发射的信号。
向识别器提供pH敏感性的又一种方式是提供一种元件，例如拉发线，其电导率根据识别器的环境的pH而修改。例如，识别器可包括导电迹线或线，其在识别器暴露于某个pH时溶解。此元件的pH敏感性可由元件的材料(例如镁、锌或在酸性条件下溶解的其它金属)和/或适当的涂层提供。当存在该元件时，识别器发射第一信号，而当元件溶解或以其他方式被破坏时，识别器发射第二信号。可选地，识别器可包括导电迹线或电线，其在识别器暴露于某个pH时产生。例如，CuCl的迹线在暴露于酸性条件时将转换成Cu金属，以产生导电元件。再次，所述材料可由为识别器赋予pH敏感性的适当涂层覆盖。当导电元件不存在时，识别器发射第一信号，而当产生所述元件时，识别器发射第二信号。
一种给定方法可包括对受检者施用单个识别器单元或者两个或更多识别器单元，例如第一、第二及甚至第三或更多识别器单元。因此，一种给定方法可包括单个识别器单元的施用。可选地，一种给定方法可包括向受检者施用两个或更多例如三个或更多、四个或更多、五个或更多、十个或更多、十五个或更多、二十个或更多等的识别器单元。在给定方法中采用多个识别器单元的场合，可在同一时间或不同时间对受检者施用多个识别器单元。
如上所述，所用的识别器单元可以是环境敏感的。在采用两个或更多环境敏感识别器单元的一些情况下，识别器单元可以响应于不同的环境条件。因此，一种给定方法可包括对受检者施用响应于第一环境条件(如酸性条件)的第一环境敏感标识器和响应于第二环境条件(如碱性条件)的第二环境敏感标识器。在这样的情况下，标识器可以对各种不同类型的环境条件例如pH敏感。
根据需要，标识器的施用可与液体和/或食品的施用协调。例如，受检者可被指示随食物包括特定类型的食物或膳食一起、随液体一起或在禁食期间、在一天的不同时间等摄入标识器，以得到与其他类型的相关信息如热量摄入、一天的时间等联系的信息。
在对受检者施用一个或多个识别器单元之后，如上所评论的，从一个或多个识别器单元发射的一个或多个信号由系统的与身体相连的接收器检测。通过受检者的皮肤和其他身体组织来执行电流检测。在一些情况下，接收器被配置成同时检测多个独特的电流特征，每个电流特征来自各自的识别器单元，例如可摄入事件标识器或离子发射模块。来自相应数量的识别器单元的不同的独特电流特征的数量可以是2个或更多、5个或更多、10个或更多，其可从不同识别器单元发射。
为了向体外数据处理器提供数据，信号接收器可以被配置成将所接收的信号的数据重新传输到所述受检者的外部位置。可选地，信号接收器可以被配置成由外部询问器件询问以向外部位置提供所接收的信号的数据。在此评估中采用的特定方案可根据所确定的特定功能变化。在一些情况下，评价方案是基于检测指示识别器单元遇到所关注的预定环境条件的信号的方案。例如，评估方案可以是基于在特定生理位置处的特定pH如胃或食道中的低pH的检测的方案，其可用于确定GERD的存在(如下更详细评论的)。在这些类型的评估方案中，可采用单个识别器单元，或可采用多个识别器单元。例如，可以采用发射不同编码信号的一组两个或更多识别器单元，其中两个标识器被配置成在不同的位置发射信号。
可选地，每个识别器单元可以被配置成在不同生理目标部位处发射信号，例如，其中每个识别器单元被配置成在不同的目标生理部位处被启动。例如，第一识别器单元可在口腔中被启动，第二识别器单元可在食道中被启动，第三识别器单元可在小肠中被启动以及第四识别器单元可在大肠中被启动。这样的识别器单元组可用于诊断应用中以确定消化系统的功能，例如通过消化道的能动性、胃排空等。例如，通过记录每个识别器单元何时发射其各自的信号，可产生信号相对于时间的图，从该图可得到有关消化道功能的信息。
代替使用指示识别器单元与预定环境条件(如pH值)接触的信号，所采用的评估方案可监控在施用之后相对于时间和位置的所检测的信号。这种信息可以用来确定胃肠功能的不同方面，例如总GI通过时间或胃肠道的部分所特有的通过时间，如胃排空时间、小肠通过时间、全结肠通过时间等。
一种给定评估方案可以是采用仅从识别器单元22得到的数据的方案，或者可以是采用从识别器单元得到的数据和一个或多个其他类型的数据的方案，所述其他类型的数据为例如生理数据(包括但不限于胃电图、温度、心率、血压等)、非生理的患者特定的数据(包括但不限于性别、年龄、身高、体重、用药史、摄食记录、运动史等)、环境数据(包括但不限于空气温度、压力等)以及从被配置成得到内脏电图如肠电图包括胃电图的与身体相连的信号接收器得到的信号。被用来得到内脏电图的具体方案可变化。例如，具体方案可仅采用代表由所关注的器官生成的电信号的数据，即器官特定的肌电数据。可选地，具体方案可采用器官特定的肌电数据和其他类型的数据，如上所评论的。一种给定方案可包括将数据与基准数据比较，以识别与标准的偏差，基准数据即对照数据。另一种方法是将pH相关的数据与肌电活动相关的数据结合，从而为医师提供用于诊断和决策的有力工具。根据需要，一种给定方案可包括噪声消除算法的使用。
在采用识别器单元的场合，一种给定方案可以按照若干不同的方式采用识别器单元的信号。例如，由识别器单元发射的信号可用作所得到的内脏电图的独立校准。在一些情况下，在一种给定方法中所采用的系统使用被配置成从施用并启动起发射频率随时间变化的信号的识别器单元。在这些实施方式中，由识别器单元发射的信号的频率的变化可以被设计成加强或抵消所关注的器官的肌电信号，如胃波。例如，识别器单元可以被配置成在它穿过胃肠道时发射从高频向低频变化的信号。从与身体相连的接收器得到的数据然后可被用来生成高频和低频信号图。高频信号可用作在识别器单元穿过胃肠道时识别器单元的位置相对于时间的图，而低频信号可用于生成胃电图，只有与器官的肌电波共振的那些信号被用于提高信噪比。
如上关于图3所讨论的，在根据本发明的另一方面的其它系统中，识别器单元自身可记录所关注的肌电信号，并将包括有关这些肌电信号的信息的数据传输到系统的一个或多个与身体相连的接收器。例如，识别器单元可被配置成包括功能块，所述功能块检测所关注的肌电信号并然后将所产生的检测的肌电数据传输到系统的一个或多个与身体相连的接收器单元。
一种给定方法可以根据需要包括生成临床诊断评价，其中所述评价可采取单个值的形式或者就所关注的一个或多个参数而言比数值更加详细(例如，其中评价以报告单的形式被提供)。使用适当的算法，本发明的内脏电图可与一个或多个其他的数据流结合，以便提供这种评价。本发明的方法可以用于各种不同类型的受检者。
现参考图7，示出用来确定患者或受检者的胃肠通过时间的方法的示意图。患者被提供了三个不同的识别器单元胶囊92，一个在早上摄入，一个在下午摄入以及一个在晚上摄入。每个胶囊92包括一组多个不同的识别器单元，其被配置成在它们到达胃肠道94的不同部分时发射信号，例如上文所述的标识器组。在施用之后，每个胶囊92在胃肠道94的胃中溶解并被活化为活性胶囊92a，其中每个活性胶囊92a产生独特的电流特征。识别器单元在其达到其预定位置时发射电流特征。在电流信号中编码的信息由接收器单元96记录。接收器单元96然后将数据无线地转发到体外数据处理器98，例如PDA或膝上型计算机。处理器98对所接收的数据执行评估方案以向用户输出(例如通过在监视器上显示图形用户界面)通过时间结果(例如总的通过时间、结肠通过时间等)。通过PDA或膝上型计算机向用户示出的图形是示出胃的排空百分比与时间的关系的图形。
本发明的方法可以用于各种不同类型的受检者，包括“哺乳动物”、食肉动物(如狗和猫)、啮齿动物(如小鼠、豚鼠和大鼠)以及灵长类动物(如人、黑猩猩和猴子)。
本发明的方法和系统在各种不同的应用中得到使用，其中期望生成内脏电图例如肠电图如胃电图。所关注的应用包括本发明的肠电图被用来评估胃肠功能的那些应用。例如，本发明的胃电图在胃能动性、胃周期、胃肠通过时间、胃容积等的确定中得到使用。所关注的应用包括在受检者的胃肠病症的诊断和/或监控中使用本发明的内脏电图。使用本发明的胃电图可评估的受检者的胃肠紊乱包括但不限于：胃能动性病症如胃轻瘫。所关注的一个应用是受检者的胃能动性病症的评估，其中评估包括受检者的胃能动性病症的存在的诊断以及对胃能动性病症监控受检者的治疗过程(例如以确定给定治疗方案是否对所关注的胃能动性病症有期望的治疗作用)。
使用本发明的方法可实现评估的一种胃能动性病症是胃轻瘫。也被称为延迟性胃排空的胃轻瘫，是由胃的部分麻痹构成的医学病症，导致食物在胃中停留的时间段比正常长。当迷走神经被破坏并且胃和肠的肌肉不能正常工作时，胃轻瘫可能发生。食物然后缓慢地移动或停止通过消化道移动。与胃轻瘫相关的症状包括呕吐、腹胀、腹痛或不适以及早饱。
所关注的受检者包括例如通过使用胃轻瘫的一个或多个症状而至少怀疑患有胃轻瘫的那些受检者。在评估个体的胃轻瘫时，识别器单元在被启动时发射受控电流特征。在识别器单元进入胃肠道时，接收器器单元的运动和位置可根据时间被监控。例如，通过绘制位置与时间的关系曲线，可很容易确定在识别器单元的摄入后识别器单元从胃进入小肠的时间，并从而确定胃排空时间。可选地，可采用一组两个或更多识别器单元，其标识器可响应于不同的环境条件。例如，一个受检者可以施用响应于酸性条件的第一识别器单元和响应于碱性条件的第二识别器单元。如果这些标识器在同一时间被施用并且然后每个标识器的信号检测时间被记录，则通过比较从酸性pH和碱性pH响应标识器得到信号的时间，可以很容易地进行胃排空时间的测量。例如，可用从施用到检测到来自碱性pH响应标识器的信号的时间减去从施用到检测到来自酸性pH响应标识器的信号的时间，以便得到胃排空时间的测量。在期望时，给定参数(如位置、pH、压力等)与时间的关系曲线可被制备并与合适的对照图(换句话说，参考)比较，以得到期望的胃排空测量。
可很容易被修改以采用本申请所描述的识别器单元的评估胃轻瘫的方法包括但不限于在第20080287833、20080161643、20080064938和20040162501号美国公布申请以及第7,160,258和7,141,016号美国专利中所描述的方法，上述申请的公开通过引用被并入本文。
在期望时，本发明的方法可与诊断胃轻瘫的一种或多种其他的方法结合使用。例如，本发明的方法可用作受检者是否患有胃轻瘫的第一确定或筛选。如果这第一确定的结果是阳性的，则可以执行一个或多个其他的检验以确认胃轻瘫的存在。可与本发明的方法结合使用的其他的胃轻瘫诊断检验包括但不限于：基于症状和身体检查的诊断检验；摄入和监控同位素标识器组合物的诊断检验，上胃肠内窥镜检查；胃窦十二指肠能动性检验，其测量由胃和肠肌的收缩生成的压力；胃电图(EGG)，其记录通过胃部肌肉和控制肌肉的收缩的电信号；等等。
在期望时，本发明的方法可以进一步包括当所述方法识别出受检者患有胃轻瘫时，治疗受检者的胃轻瘫。所关注的是通过刺激胃来更正常地收缩而治疗胃轻瘫的药物。所关注的特定药物治疗包括但不限于：胃复安、吗丁啉、红霉素、奥曲肽等。在期望时，可采用外科手术，例如在胃和小肠之间产生更大的开口以便于排空胃的过程的手术。所关注的其他治疗方案包括但不限于第20060029614、20050164925、20050106167、20050090554、20030059374和20020143030号美国公布申请中所描述的那些方案，上述的公开通过引用被并入本文。
本发明的方法得到使用的其他胃能动性紊乱包括但不限于：胃节律失常如胃动过缓和胃动过速，以及胃出口梗阻、盆底功能障碍、慢性便秘及表现糖尿病和/或自主神经病变的GI病症。本发明的胃电图在其评估中得到使用的其他类型的病症包括但不限于：其他肠紊乱、膀胱紊乱、儿童安琪儿综合症以及子宫内膜异位症。本发明的胃电图得到使用的应用在第5,704,368和6,351,665号美国专利以及第20050215917号美国公布申请中被进一步评论，上述专利的公开通过引用被并入本文。如上所述，当本发明的方法被用来评估这些病症时，所述方法可进一步包括使用一个或多个其他的检验来确认诊断和/或使用一个或多个治疗方案来治疗受检者的所诊断的病症。
此外，本发明的内脏电图可在评估对不同刺激的生理反应中得到使用。在一些情况下，本发明的胃电图可用来评估个体对不同类型的食物的反应。例如，所观察到的胃电图在高卡路里含量的食物和低卡路里含量的食物之间变化。各种所观察到的胃电图因此可被用来评估个体的饮食，例如，在希望监控受检者对饮食疗程的遵守的情况下。
本方法得到使用的另一种类型的胃肠病症是GERD，以及相关的病症，如功能性消化不良。这些应用的所关注的受检者包括至少怀疑患有GERD的那些受检者。对于GERD的评估，可对受检者施用一个或多个识别器单元，其中识别器单元是pH敏感的并被配置成发射信号，通过该信号可确定给定生理部位处的pH。当接收到一个或多个信号，可得到GERD评估。例如，当患有GERD的患者接受给定的治疗方案时，不管患者正在接受的治疗方案如何，本发明的方法都可用于识别低胃pH。这个结果可用来以某种方式验证治疗方案的改变。可选地，可以采用被配置成提供信号的识别器单元，从该信号中可确定下食道pH。使用这样的环境响应识别器单元，在下食道中检测到的低pH可用作GERD的诊断标志。
在期望时，本发明的方法可与一个或多个其他的GERD诊断方法结合使用。所关注的GERD诊断方法包括但不限于：钡吞X-射线、食道测压、24小时食道pH监控和上消化道内镜(EGD)。本发明的方法可以进一步包括在通过本发明的方法评估GERD之后治疗个体的GERD。所关注的药物治疗方案包括但不限于：质子泵抑制剂(例如奥美拉唑、泮托拉唑、兰索拉唑和雷贝拉唑)；胃H2受体阻断剂(例如雷尼替丁、法莫替丁和西米替丁)；抗酸剂；海藻酸；胃肠促动剂(如西沙必利)；硫糖铝；5-HT4受体激动剂，如枸橼酸莫沙必利；等等。
应理解，本发明不限于所描述的特定实施方式，因此可变化。同样应理解，本文所使用的术语只是为了描述特定实施方式的目的，而没有被规定为限制性的，因为本发明的范围将只由所附的权利要求限定。
在提供值的范围的场合，应理解，除非上下文另外明确说明，否则下限精确到十分位，在该范围的上下限之间的和任何其它规定的每个中间值或该规定范围内的中间值包含在本发明内。这些更小范围的上下界限可以独立地包括在更小的范围中，并且也包含在本发明内，术语规定范围中的任何被明确排除的界限。在规定范围包括界限的一个或两个的场合，排除那些所包括的界限的一个或两个的范围也包括在本发明中。
除非另有规定，本文所使用的所有技术和科学术语具有与本发明所属领域的普通技术人通常理解的相同含意。虽然类似或等效于本文中所述的那些方法和材料的任何方法和材料也可以在本发明的实践或检验中使用，但是现在描述的是代表性的说明性方法和材料。
此说明书中引用的所有公布和专利通过引用被并入本文，好像每个单独的公布或专利明确地且单独地被指示为通过引用被并入，并且通过引用被并入本文以结合所引用的公布来公开和描述所述方法和/或材料。任何公布的引用是针对其在提交日前的公开，且并不应被解释为承认本发明由于在先发明不享有先于此类公布的权利。此外，所提供的公布日期可能不同于实际公布日期，可能需要独立地确认实际公布日期。
注意，如本文和所附权利要求中使用的，除非上下文明确指明，否则，单数形式的“一个”、“一种”和“所述”包括复数所指对象。还要注意的是，权利要求可被撰写为排除任何可选的要素。因此，此声明旨在用作与权利要求要素的引用有关的排他性术语诸如“只有”、“仅仅”等的使用或“否定”限定的使用的前提基础。
某些范围在本文中给出前面带术语“大约”的数值。术语“大约”在本文中用于为它之后的确切数字以及与其后的数值接近或近似的数值提供字面支持。在确定数值是否接近或近似明确表述的数值时，接近或近似未表述数值可以是给出该未陈述数值的上下文中提供明确表述的数值的实质的等同值的数值。
在阅读此公开之后，对于本领域的技术人员明显的是，本文所述和所示的每个单独的实施方式具有分离的部件和特征，在不偏离本发明的范围或精神的情况下，其可容易地与其它几个实施方式的任何特征分离或组合。任何所陈述的方法可按照所陈述的事件的顺序或逻辑上可能的任何其它顺序实施。
虽然为了理解清楚的目的已经通过说明和举例的方式相当详细地描述了上述发明，但是对于本领域的那些普通技术人员显而易见的是，在不偏离所附权利要求的精神和范围的情况下，根据本发明的教导，可对其进行某些改变和修改。

Claims (12)

1.一种用于检测肌电活动的系统，所述系统包括：
接收器单元，其能够检测电压电位变化，其中，所述接收器单元包括用于将编码信息发送到远程位置的传输模块和从邻近环境搜集信息的至少一个传感器电极；
可摄入的识别器，其与所述接收器单元通信，其中，所述识别器包括：
外壳，其包括固定到所述外壳的第一电极和第二电极；
控制单元，其电耦合到所述第一电极和所述第二电极，其中，所述控制单元改变所述第一电极和所述第二电极之间的电导；以及
检测单元，其电耦合到所述第一电极和所述第二电极，其中，所述检测单元读取周围环境以收集信息，
其中，所述第一电极和所述周围环境以及所述第二电极和所述周围环境之间的电化学反应分别产生给所述可摄入的识别器供电的电压电位，以便所述控制单元使所述可摄取识别器在广播模式和检测模式之间切换;以及
第二可摄入的识别器，其中，所述第二可摄入的识别器与所述可摄入的识别器通信，使得当所述第二可摄入的识别器在广播模式下时，所述可摄入的识别器在检测模式下，从而允许所述第二可摄入的识别器与所述可摄入的识别器通信。
2.如权利要求1所述的系统，还包括第二接收器单元，所述第二接收器单元包括至少三个电极，并且其中，所述第二接收器单元的所述电极的每一个传输由所述可摄入的识别器的每一个检测的控制信号，以在受检者体内创建检测阵列，其中，每个可摄入的识别器的位置能够被确定。
3.如权利要求1所述的系统，其中，所述可摄入的识别器测量酸性条件，而所述第二可摄入的识别器测量碱性条件。
4.如权利要求1所述的系统，其中，所述系统还包括被配置成从所述接收器单元接收数据并从所接收的数据生成内脏电图的体外数据处理器。
5.如权利要求1所述的系统，其中，所述可摄入的识别器包括固定到所述外壳的圆盘，其中，所述圆盘是不导电的，并且其中，在所述检测模式期间，所述可摄入的识别器记录与肌电活动相关的数据，而在所述广播模式期间，所述可摄入的识别器产生包括所述数据的独特电流特征。
6.如权利要求1所述的系统，其中，编码在由所述可摄入的识别器产生的独特电流特征中的信息是向所述接收器单元指示所述可摄入的识别器的启动的识别信息。
7.如权利要求1所述的系统，其中，编码在所述可摄取识别器的独特电流特征中的信息代表在检测阶段期间搜集的数据。
8.如权利要求1所述的系统，其中，所述接收器单元还包括远离所述至少一个传感器电极定位的第二传感器电极。
9.如权利要求8所述的系统，其中，所述接收器单元还包括能够检测由电压电位产生的低频电流信号和能够检测由所述可摄入的识别器产生的高频电流信号的检测模块。
10.如权利要求1所述的系统，其中，所述可摄入的识别器还包括响应于周围温度并能够记录周围温度的温度感测单元。
11.如权利要求1所述的系统，其中，所述可摄入的识别器包括能够测量周围温度的传感器。
12.如权利要求1所述的系统，其中，所述可摄入的识别器包括能够测量周围pH水平的传感器。
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US20110040203A1 (en) 2011-02-17
CA2746650A1 (en) 2010-06-17
CN102271578A (zh) 2011-12-07
WO2010068818A3 (en) 2010-08-26
SG172077A1 (en) 2011-07-28
KR101126153B1 (ko) 2012-03-22
US8583227B2 (en) 2013-11-12
TW201034617A (en) 2010-10-01
AU2009324536A1 (en) 2011-07-14

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